People with HIV, opioid (OUD) and alcohol use disorders (AUD) are concentrated within the criminal justice system (CJS). Upon release from incarceration, drug and alcohol relapse is common and contributes to poor HIV treatment outcomes, increased HIV transmission risk, recidivism and mortality. The specific aim of these two studies was to evaluate extended-release naltrexone (XR-NTX), an FDA-approved medication for OUD and AUD, as a means to improve HIV viral suppression (VS) among persons living with HIV (PLH) released from prison or jail to the community with OUD and AUD.
Two separate double-blind placebo controlled randomized trials were conducted among HIV+ inmates with (1) AUD (INSPIRE, N=100); and (2) OUD (NEW HOPE, N=93) who were transitioning to the community. Participants were randomized 2:1 to receive 6 monthly injections of XR-NTX or placebo starting one week prior to release and continuing for 6 months post-release. The primary outcome was the proportion that maintained VS (<50 copies/mL) at 6 months in an intention to treat (ITT) analysis.
Baseline characteristics did not statistically significantly differ between treatment groups in either study. For INSPIRE, the ITT analyses revealed the XR-NTX group was statistically more likely to achieve VS as compared to placebo at 6 months post-release (56·7% vs. 30·3%; p=0.015). After controlling for other factors, receipt of XR-NTX remained independently predictive of VS (aOR=4·54; 95%CI=1·43-14·43, p=0.009). Participants receiving 3 or more injections, irrespective of allocation, were also more likely to achieve VS (aOR=6.34; 95%CI=2.08-19.29, p=0.001 respectively), as were reductions in alcohol consumption (aOR=1·43; 95%CI=1·03-1·98, p=0.033) and white race (aOR=5·37; 95%CI=1·08-27·72, p=0.040). For NEW HOPE, the ITT analyses revealed that the XR-NTX group was more likely to achieve VS at 6 months (37.9% to 60.6%, p=0.002 as compared to placebo (55.6% to 40.7%, p=0.294). The XR-NTX group was also more likely than placebo to improve to VS (30.3% vs.18.5%); maintain VS (30.3% vs. 27.3); and less likely to lose VS (7.6% vs. 33.3%) at 6 months (p=0.041). Independent predictor of VS was only receiving XR-NTX (aOR=2.90; 95% CI=1.04-8.14, p=0.043). There were no serious adverse events in either study.
XR-NTX can improve or maintain HIV VS after release to the community for incarcerated PLH with OUD and AUD, thus benefiting both individual and public health.